Background Opioid-induced constipation (OIC) has negative effects on quality of life (QOL). Prucalopride is a new, selective 5-HT₄ agonist and enterokinetic with strong clinical data in chronic constipation. This study investigated the efficacy, safety, and tolerability of prucalopride in patients with noncancer pain and OIC. Methods A phase II, double-blind, placebo-controlled study of 196 patients randomized to placebo (n = 66), prucalopride 2 mg (n = 66) or 4 mg (n = 64), for 4 weeks, was carried out. The primary endpoint was the proportion of patients with increase from baseline of ≥1 spontaneous complete bowel movement (SCBM)/week. Secondary endpoints [proportion of patients with ≥3 SCBM/week, weekly frequency of (SC)BM, severity of constipation, and efficacy of treatment], adverse events (AEs), and safety parameters were also monitored. Results More patients had an increase from baseline of ≥1 SCBM per week (weeks 1–4) in the prucalopride groups [35.9% (2 mg) and 40.3% (4 mg)] versus placebo (23.4%), reaching statistical significance in week 1. Over weeks 1–4, more patients in the prucalopride groups achieved an average of ≥3 SBM per week versus placebo (60.7% and 69.0% versus 43.3%), reaching significance at week 1. Prucalopride 4 mg significantly improved patient-rated severity of constipation and effectiveness of treatment versus placebo. Patient Assessment of Constipation-Symptom (PAC-SYM) total scores and Patient Assessment of Constipation-Quality of Life (PAC-QOL) total and satisfaction subscale scores were improved. The most common AEs were abdominal pain and nausea. There were no clinically relevant differences between groups in vital signs, laboratory measures or electrocardiogram parameters. Conclusion In this population with OIC, prucalopride improved bowel function and was safe and well tolerated.

Purpose The optimal timing of ostomy closure is a matter of debate. We performed a systematic review of outcomes of early ostomy closure (EC, within 8 weeks) and late ostomy closure (LC, after 8 weeks) in infants with necrotizing enterocolitis. Methods PubMed, EMbase, Web-of-Science, and Cinahl were searched for studies that detailed time to ostomy closure, and time to full enteral nutrition (FEN) or complications after ostomy closure. Patients with Hirschsprung’s disease or anorectal malformations were excluded. Analysis was performed using SPSS 17 and RevMan 5. Results Of 778 retrieved articles, 5 met the inclusion criteria. The median score for study quality was 9 [range 8–14 on a scale of 0 to 32 points (Downs and Black, J Epidemiol Community Health 52:377–384, 1998)]. One study described mean time to FEN: 19.1 days after EC (n = 13) versus 7.2 days after LC (n = 24; P = 0.027). Four studies reported complication rates after ostomy closure, complications occurred in 27 % of the EC group versus 23 % of the LC group. The combined odds ratio (LC vs. EC) was 1.1 [95 % CI 0.5, 2.5]. Conclusion Evidence that supports early or late closure is scarce and the published articles are of poor quality. There is no significant difference between EC versus LC in the complication rate. This systematic review supports neither early nor late ostomy closure.

In the past, an anteriorly located anus was often misdiagnosed and treated as an anorectal malformation (ARM) with a perineal fistula (PF). The paper aims to define the criteria for a normal anus, an anterior anus (AA) as an anatomic variant, and milder types of ARM such as congenital anal stenosis (CAS) and PF. An extensive literature search was performed by a working group of the ARM-Net Consortium concerning the subject “Normal Anus, AA, and mild ARM”. A consensus on definitions, clinical characteristics, diagnostic management, and treatment modalities was established, and a diagnostic algorithm was proposed. The algorithm enables pediatricians, midwives, gynecologists, and surgeons to make a timely correct diagnosis of any abnormally looking anus and initiate further management if needed. Thus, the routine physical inspection of a newborn should include the inspection of the anus and define its position, relation to the external sphincter, and caliber. A correct diagnosis and use of the presented terminology will avoid misclassifications and allow the initiation of correct management. This will provide a reliable comparison of different therapeutic management and outcomes of these patient cohorts in the future.

Introduction Rectal suction biopsy (RSB) is performed on clinical and radiological suspicion of Hirschsprung disease (HD). Positive histochemical staining for acetylcholinesterase in the lamina propria mucosa and muscularis mucosa together with the absence of ganglion cells in the submucosa confirms HD. A second RSB or a full-thickness biopsy is done in case of doubt. The primary aim of the study was to evaluate the effectiveness of RSB in diagnosing HD. In addition, the results of RSB in preterm born infants were analyzed. Methods This retrospective study included all infants younger than 1 year who had RSB for HD suspicion from January 2004 to April 2014. All histopathological results were reviewed. Sensitivity, specificity, positive, and negative predictive values of the first RSB were calculated. Results In total, 183 patients (99 boys, mean age 11 weeks) were included. HD was diagnosed in 55 patients (30%). A second biopsy was performed in 12/55 patients (22%), which confirmed HD in 9 patients. One patient did not undergo a second biopsy, but HD was excluded based on clinical follow-up. Thus, HD was eventually excluded in 4 of the 55 patients with a positive first RSB. HD was excluded in the first biopsy in 128 patients (70%). In 19 of those (15%), a second biopsy was done, which led to the diagnosis of HD in 10 patients. Two patients with negative biopsy results were still operated on because of the high clinical suspicion for HD, and the histopathological analysis on the operative specimen confirmed HD. Thus, HD was eventually diagnosed in 12 out of 128 patients. Thus, the sensitivity of the first RSB was 81% and the specificity was 97%. The positive predictive value was 93% and the negative predictive value was 91%. A subanalysis for the 38 preterm born infants was done, with a mean conceptional age at the time of biopsy of 44 weeks (range 34–82). Sensitivity and specificity of RSB were 83 and 97%, respectively, with one false-positive and one false-negative results. Conclusion The overall sensitivity of the RSB was 81%, with 12 false-negative results, in which cases extra biopsies had been necessary. The specificity was 97%, with four false-positive findings. We found that RSB can also be reliably and safely performed in preterm born infants, which implies there is no reason to postpone a RSB in those infants. New methods, such as calretinin staining, must be considered to achieve better effectiveness of the RSB for diagnosing HD.

Purpose: The STAT trial is a multicenter randomized controlled trial in 12 centers worldwide aiming to determine the most effective operation for neonates with necrotizing enterocolitis (NEC) requiring intestinal resection: stoma formation (ST) or primary anastomosis (PA). Methods: Infants having a primary laparotomy for NEC were randomized intraoperatively to PA or ST if the operating surgeon thought that both were viable treatment options for that patient. The primary outcome (duration of parenteral nutrition [PN]) was evaluated by Cox regression. Results: Eighty patients were recruited from 2010 to 2019. Infants undergoing anastomosis finished PN significantly earlier than patients undergoing stoma (hazard ratio PA vs. ST 2.38, 95% CI 1.36–4.12 p = 0.004). There was no difference in mortality between the two groups (PA 4/35 vs. ST 8/38 p = 0.35) or in the rate of complications requiring further unplanned operations (p = n.s.). Multiple intestinal complications were more frequent in the stoma group compared to the anastomosis group (ST 12/26 vs. PA 5/31, p = 0.02, Fisher’s Exact test). Conclusion: At laparotomy for NEC, when there is no disease distal to resected intestine, primary anastomosis should be performed as it enhances the recovery from NEC, reduces the risk of multiple intestinal complications and does not increase adverse outcomes.

A 73-year old man presented with dysphagia for liquid and solid food. Barium contrast study of the esophagus and esophagoscopy demonstrated a fibrovascular polyp. This, almost 10 cm benign esophageal tumor, was removed surgically by a cervical esophagotomy. A fibrovascular polyp is a rare benign tumor of the esophagus, which, however, may give serious complications as asphyxia resulting from laryngeal obstruction leading to sudden death.